| Methods |
Study design: parallel RCT Time frame: January 2003 to December 2008 Follow‐up period: mean 3.2 years |
| Participants |
Country: International Setting: multicentre Inclusion criteria: patients treated with HD or HF for at least 3 months and aged 50 to 80 years Number (treatment/control): 1389/1384 Age (mean ± SD) years: treatment group (64.1 ± 8.6); control group (64.3 ± 8.7) Sex (M/F): treatment group (851/538); control group (812/512) Exclusion criteria: statins therapy 6 months, expected kidney transplantation within 1 year, and serious haematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) predicted to limit life expectancy to < 1 year; history of malignant condition, active liver disease (indicated by an AST level > 3 x ULN), uncontrolled hypothyroidism, and an unexplained elevation in CK level > 3 x ULN |
| Interventions |
Treatment group
Control group
|
| Outcomes |
Primary endpoint: Time to a major cardiovascular event defined as non‐fatal MI, non‐fatal stroke or death from cardiovascular causes Secondary endpoints: all‐cause mortality, cardiovascular event–free survival (i.e. freedom from non‐fatal MI, non‐fatal stroke, cardiovascular cause mortality, and all‐cause mortality), procedures performed for stenosis or thrombosis of the vascular access for long‐term HD (arteriovenous fistulas and grafts only), and coronary or peripheral revascularisation, death from cardiovascular causes, and death from non‐cardiovascular causes |
| Notes |
Industry funding received |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
NR |
| Allocation concealment (selection bias) |
Unclear risk |
NR |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
All MIs, strokes, and deaths were reviewed and adjudicated by a clinical endpoint committee whose members were unaware of the randomised treatment assignments to ensure consistency of the event diagnosis |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No patients were lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Published reports included all expected outcomes |
| ITT analysis |
Low risk |
Conducted |
